Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer
NCT ID: NCT05344339
Last Updated: 2025-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
320 participants
INTERVENTIONAL
2022-10-08
2028-12-31
Brief Summary
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Hypothesis: Billroth-II modified method is non-inferior to Roux-en-Y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.
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Detailed Description
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At our center, reconstruction after distal and sub-total gastrectomy including B-I, B-II, B-II with Braun anastomosis, and R-Y, depended mostly on surgeons' preferences. From 2018, to decrease bile reflux rate while not increasing operation time, we applied modified B-II technique with 3-5 sutures between the afferent loop to the gastric remnant. This study was conducted to evaluate the efficacy of this method by comparing it with the R-Y method.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Billroth-II modified
An opening will be made at jejunum 25 cm from Treitz's ligament. Another at greater curvature of the stomach right above transected line. A straight stapling device will be used to make isoperistaltic anastomosis at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture and 3 -5 sutures to attach afferent loop to the remnant stomach
Distal gastrectomy
Reconstruction after Distal Gastrectomy
Roux-en-Y
Jejunum will be transected 25 to 30 cm from Treitz's ligament. Marginal vessels will be transected if needed to make sure the loop will reach the stomach without tension. Isoperistaltic gastrojejunostomy will be made at posterior wall of the stomach. After checking for bleeding, common entry hole will be closed using running suture. Jejunojejunal mesenteric defect and Petersen's defect will be closed.
Distal gastrectomy
Reconstruction after Distal Gastrectomy
Interventions
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Distal gastrectomy
Reconstruction after Distal Gastrectomy
Eligibility Criteria
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Inclusion Criteria
* Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
* Age from 18- to 80-year-old
* Agreed to participate in study with written inform consent
Exclusion Criteria
* An American Society of Anesthesiology (ASA) score of higher than 4
* Concurrent cancer or history of previous other cancers
* Previous gastrectomy
* Complications including bleeding, perforation required emergency gastrectomy
18 Years
80 Years
ALL
No
Sponsors
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University Medical Center Ho Chi Minh City (UMC)
OTHER
Responsible Party
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Principal Investigators
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Long D Vo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center HCMC, VN
Locations
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University Medical Center Ho Chi Minh City
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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L D.
Role: backup
Other Identifiers
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15/GCN-HDDD
Identifier Type: -
Identifier Source: org_study_id
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